1. Field of the Invention
The present invention relates to a device that automatically takes a biopsy or other sample of human or animal tissue and delivers a coagulant or other material to the biopsy incision track in order to plug the track and prevent bleeding, to provide a marker for future reference so that it may be located in a subsequent medical/surgical procedure or place a material or chemical to prevent seeding of cells from the biopsy site.
2. Related Art
In modern medical practice small tissue samples, known as biopsy specimens, are often removed from tumors, lesions, organs, muscles and other tissues of the body for histological evaluation and diagnosis. Such removal of tissue samples can be accomplished by open surgical technique (i.e., removal of a small sample of tissue through a small surgical incision using a local anesthetic), or through the use of a specialized biopsy instrument such as a biopsy needle. After the tissue samples have been removed, they are typically subjected to diagnostic tests or examinations such as a) gross and microscopic examination to determine cytology and/or histology, b) biochemical analyses to determine the presence or absence of chemical substances which indicate certain disease states, c) microbiological culturing to determine the presence of bacteria or other microbes, and/or d) other diagnostic procedures. The information obtained from these diagnostic tests and/or examinations can then be used to make or confirm diagnoses and/or to formulate treatment plans for the patient.
Special Considerations Relating to Biopsy and Plugging the Biopsy Track to Prevent Bleeding; Liver Biopsy
Excision biopsy of the liver has traditionally been the gold standard for assessing the extent of injury and determining prognosis in chronic viral hepatitis, non alcoholic steptohepatitis, fatty liver disease and liver cancer. A significant complication that frequently occurs is bleeding from the biopsy site. Significant hemorrhage occurs in 0.35 to 0.5% of all procedures while evidence of sub-clinical bleeding, as detectable by ultrasound 24 hours post biopsy, has been reported in up to 23% of patients. A smaller amount of surface bleeding is almost universal and is frequently associated with mild to moderate pain.
Excision biopsies from other organs, such as the lungs, also exhibit a relatively high complication rate due to hemorrhagic incidents and pneumothorax. Also with kidney biopsies and biopsies of other organs, perfuse bleeding is considered the most important complication.
In order to prevent bleeding resulting from the biopsy, it has been proposed to plug the biopsy channel with a hemostatic agent. A typical hemostatic agent can be Gelfoam (Pharnacia & Upjohn), Avitene (Davol, Inc), FloSeal (Baxter International) or other similar agent. The treatment of a biopsy track with an injectable absorbable coagulant to facilitate homeostasis in conjunction with procuring a biopsy provides substantial advantages in comfort over external pressure methods or the insertion of a pledget of Gelfoam foam as described in U.S. Pat. No. 6,086,607, which must be inserted through a previously inserted catheter. The insertion of a catheter involves a longer procedure as well as the risk of the catheter shifting while the operator switches or disconnects from the aspiration biopsy syringe to the coagulant delivery syringe. In addition, the present invention also provides advantages over the insertion of an absorbable sponge material in a dry state with an applicator. A dry piece of sponge material must be cut to the particular size of the biopsy track and does not swell to fill the track until the blood has sufficiently saturated the sponge material which can take a significantly amount of time and provides inadequate local compression.
From Austrian Pat. No. 384,165, a biopsy needle device of the initially defined kind is known, with which the cannula has a curved partition wall towards the internal limitation of the cannula lumina. Therein, the partition wall does not reach immediately to the front end of the cannula so that the biopsy channel and the application channel communicate in the region of the tip of the cannula. The multi-lumen biopsy device according to Austrian Pat. No. 384,165 enables the collection of tissue and the application of substances plugging the puncture track in coordination with the puncturing procedure in one operating cycle, thus largely shortening the time of intervention.
U.S. Pat. No. 4,850,373 and related EP patents 243341 A, B1 etc., also describes a biopsy needle device having a two lumen cannula, a biopsy channel of constant cross section and one application channel. The application channel is formed by a tube eccentrically slipped over the biopsy channel wall. Furthermore, the biopsy channel is described as a non-circular tubular structure with its channel wall flattened in cross section such that an application channel is formed between the flattened side of the biopsy channel wall and the outer application tube. In addition, surface contact exists between the non-flattened side of the biopsy channel wall and the application tube.
A common surgical material used to control bleeding is Gelfoam®, which is supplied in either a powder form or as an implantable sponge. Sterile sponges, such as Gelfoam®, are prepared in dry sterile sheets that are used as packing material during surgery for control of bleeding. The sponge sheets are left in the surgical site after surgery to stop bleeding and are absorbed by the body in 1 to 6 weeks. A number of techniques have used these absorbable sterile sponge materials to plug a biopsy track to minimize or prevent bleeding. The absorbable sponge provides a mechanical blockage of the track, encourages clotting, and minimizes bleeding though the biopsy track. Despite the advantages of using absorbable sponge to plug a biopsy track this technique has not achieved widespread use because of difficulty in preparing and delivering the sponge material into the biopsy track.
One example of a biopsy wound closure device using an implantable sponge is described in U.S. Pat. No. 5,388,588. According to this patent, a circular sponge of an absorbable foam material is precut and inserted into a biopsy site by an applicator rod having the sponge positioned on the end. Once the sponge is implanted, the sponge absorbs blood and swells to fill the track preventing further bleeding at the biopsy site. However, the sponge is difficult to deliver and expands slowly once delivered. In addition, this delivery method can only deliver a sponge of a limited size that provides less local compression than desired and may incompletely fill the target site. Further, bleeding may continue along sections of the biopsy track where no sponge has been delivered.
Another example of a Gelfoam® inserting device to facilitate hemostasis is described in U.S. Pat. No. 6,086,607. According to this patent, a method of cutting a piece of Gelfoam® sponge from a sheet of the material, folding the strip to form a pledget with one end of different cross section than the other end, and inserting the pledget in an adapter to compress the pledget and for attachment to a syringe for delivery of the pledget to the tissue. The adapter is attached to a cannula that was previously inserted into the organ being biopsied and the Gelfoam® is inserted into the tissue through the cannula.
Cutting Needle Technique
As can be seen from Table 1, many cutting biopsy surgical appliances are currently known. Typically, the instrument consists of a long, thin probe, termed a stylet, within a close-fitting hollow needle, termed a cannula. The stylet and cannula are contained within or attached to a firing device that first projects the stylet into the tissue, followed immediately by the cannula. The stylet has a notch into which tissue will prolapse when the stylet enters the tissue. As the cannula slides over the stylet, a small piece of tissue is then severed from the organ mass and captured within the notch of the stylet. The instrument is then withdrawn and the piece of tissue removed from the stylet for evaluation.
TABLE 1Commercially Available Cutting/core Biopsy DevicesAutomated Cutting DevicesCR BardBard Max-Core Disposible BiopsySystemCooke IncCoaxial Quick-Core Biopsy SetsBoston ScientificASAP ™Semi-Automated Cutting DevicesAllegiance Healthcare CorpTemno Biopsy SystemAvid MedicalSpring loadedRanfax MedicalRemington MedicalRemington Sharp CutCone InstrumentsTZ Spring loaded
Griffith, U.S. Pat. No. 3,477,423, was one of the first to describe an economical and simplified, biopsy needle device in which a cannula is projected forward over the stylet with a recessed collection notch such that the tissue within the notch is severed and retained within the cannula for retrieval. Improvements over the years have lead to single handed, semi automatic driving devices as described by U.S. Pat. No. 4,944,308, U.S. Pat. No. 5,368,045 and U.S. Pat. No. 5,951,489.
Special Considerations Relating to Biopsy and Delivering a Marker Material: Breast Biopsy
Breast cancer is presently the most common cancer in women and is the second leading cause of cancer deaths in women. Periodic physical and radiographic examination of the breasts (mammography) is important for early detection of potentially cancerous lesions in women over 40 years of age. In mammography, the breast is compressed between two plates while specialized x-ray images are taken. If an abnormal mass in the breast is found by physical examination or mammography, ultrasound may be used to determine whether the mass is a solid tumor or a fluid filled cyst. Cystic lesions are generally benign and the diagnosis of a cystic lesion is often confirmed by needle aspiration of fluid from the interior of the cyst and immediate diagnosis. However, solid masses are usually subjected to some type of tissue biopsy to determine if the mass is cancerous. This determination requires that the tissue be processed which may require 24 to 48 hours.
Therefore in order to locate the site of the biopsy and cancerous tissue for removal or radiographic treatment at a subsequent procedure, the site is marked, either externally or internally, with a biopsy site marker. Various types of biopsy site markers have been known in the prior art. U.S. Pat. No. 2,192,270 (Carswell, Jr.) and U.S. Pat. No. 5,147,307 (Gluck) describes externally applied markers. Additionally, the prior surgical procedures have included radiographically visible markers that may be introduced into the biopsy site such as marker wires that are inserted through the biopsy needle after a tissue sample is removed and are thereafter allowed to remain protruding from the patient's body. U.S. Pat. No. 6,161,034 (Burbank) describes various chemical preparations and methods for marking biopsy sites which remain present and detectable for up to 5 to 8 months from the initial biopsy. A method for simultaneously taking the biopsy sample and delivering the marker material is not described.
In co-pending application U.S. patent application Ser. No. 10/858,112 (Krause) for a “Biopsy and Delivery Device”, filed Jun. 1, 2004, the forgoing problems were overcome. This application teaches the combination of the multi lumen, concentric needle device providing an assembly for obtaining the biopsy and an application channel with a syringe for delivering the application material using a mechanized delivery system. The prior art does not describe the combination of a cutting needle biopsy device with a syringe application device for delivery of the application material and a device which automatically takes the biopsy and delivers the application material.
The present invention, as described herein, provides a device which facilitates the means to take the biopsy specimen and deliver a hemostatic agent to minimize the bleeding from the biopsy tract. The invention describes an electro-mechanical device to accomplish the procedure. Other mechanisms such as pneumatic, hydraulic, magnetic and electrical could also be used to perform the same tasks as known by those skilled in the art.